By Graeme Horne,
Published in: Sci of Stability Conference
Published on: August 14, 2019
Conclusion Points: • Predictive physical stability modelling de-risked the late-stage development of a chemically stable BCS class II SDD • ASAPprime® successfully predicted rate of crystallization over 12 months in clinically relevant packaging • Predictive stability modelling can be applied to understanding the physical stability profile of chemically stable SDDs that have similar mechanisms of recrystallisation • Prone to initial phase separation, low miscibility, low MW, low Tg • Application of predictive stability approaches to physical stability broadens the opportunity to progress NCE’s with otherwise unfavorable pharmaceutical profiles Key words: Commercial, Manufacture, Model
